Actively Recruiting
Precision-Based Genomics in Prostate Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-04-24
2000
Participants Needed
11
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Prostate cancer is the most common cancer and the second leading cause of death in males in the United States. Researchers want to find additional gene mutations that may increase a man s risk for prostate cancer and may affect how aggressive the disease is. Objective: To look at gene mutations in men with prostate cancer as well as the course of their disease to better understand how gene mutations relate to the way the cancer progresses and responds to treatment. Eligibility: Adult males 18 and older with prostate cancer who have at least one of the gene mutations researchers want to study and/or have been treated for their cancer and have had complete elimination of their cancer or stable disease for a long time. Design: Participants will be screened with a review of their medical records. Their gene test results will be reviewed, if available. They will be asked questions over the phone or in person. Participants do not need to visit the NIH for this study. But if they visit NIH for another study, their data and test results will be collected. They may give blood and urine samples. They may give leftover tumor samples. These samples will be used to study their genes. Participants who do not come to NIH on regular basis will be contacted every 6 months by phone or e-mail. They will be asked questions about their health. Data from their medical records will be collected. Participants will have testosterone and prostate-specific antigen (PSA) tests. Participants may be invited to NIH to give blood samples for research. Participants on this study will be followed for life.
CONDITIONS
Official Title
Precision-Based Genomics in Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate cancer
- Known germline and/or somatic variants in PIK3 and/or AKT, PALB2, BRIP1, RAD50, RAD51, RAD54, RB1, SPOP, Wnt/B-catenin pathway, CDK12, and/or MMR genes: MLH1, MSH2, MSH6, PMS2, and EPCAM and/or TMB-high (\u2265 10 mutations/megabase or blood TMB \u2265 16 mutations/megabase) or deemed an exceptional responder
- Age 18 years or older
- Ability to understand and willing to sign informed consent
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Actively Recruiting
4
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
5
Dana Farber Cancer Institute, Boston, MA
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10007
Actively Recruiting
8
Mount Sinai Hospital
New York, New York, United States, 10029
Not Yet Recruiting
9
Weill Cornell Medicine
New York, New York, United States, 10065
Not Yet Recruiting
10
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Not Yet Recruiting
11
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
K
Katherine O Lee-Wisdom, R.N.
CONTACT
F
Fatima H Karzai, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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